Education, Training & Support
The REGI Unit supports the training and education of Barwon Health researchers in research ethics, research design and methods, and ethics applications. We are available for one on one and small group education, training, and advice sessions during business hours. Please contact [email protected] to book a suitable time.
Statistical Support: Data science consulting and training
Whether you have data and you're not sure what to do with it, you have an idea in mind but you're not sure how, or indeed what data to collect; or you wish to upskill your team on data analysis/ interpretation techniques, Barwon Health’s Biostatistics Service is here to help with exactly that.
For more information, feel free to contact the Biostatistician, Dr StellaMay Gwini on 03 4215 9624 or [email protected]
Education and training about clinical trials
Good Clinical Practice (GCP) Training
The principles of GCP have their own origin in the World Medical Association's Declaration of Helsinki. The Declaration of Helsinki was a response to the atrocities revealed during the Nuremburg trials conducted after World War II. The authors of this declaration sought to ensure that human participants involved in clinical research would, in future, have their rights, safety, and well-being placed above all other considerations in clinical research. The documents has been revised several times since it was first published in 1964.
The Declaration of Helsinki was used as a basis for the development of guidance for the conduct of clinical trials by the International Conference on Harmonisation (ICH). Originally developed for commercially sponsored late phase drug trials, this guidance has become known as the 'Good Clinical Practice' (GCP) guidelines, although the guidelines apply to clinical research rather than clinical practice. The GCP guidelines details the involved parties' responsibilities, requirements for trial documentation, protocol amendments, reporting lines for adverse events, and provision of medical care for trial participants.
The Therapeutic Goods Administration (TGA) has adopted the European Union version of these guidelines in Australia. The TGA advice includes specific comments from the TGA relevant to the Australian context.
GCP Requirements for Principal Investigators of clinical trials
In keeping with best practice, it is a Barwon Health requirement that Principal Investigators on all clinical trials must hold current GCP certification.
The REGI Unit recommends GCP training courses offered by ARCS Australia.
Applied GCP training for investigational sites and sponsor representatives (Certificate 1, 2 and 3) can be undertaken at the researcher's own pace and takes approximately 10 hours to complete. The training is principally focused on best practice in clinical trials research, but is sufficiently broad in scope so as to benefit all clinical researchers. Upon completion of the program, researchers should have a good understanding of Australian regulations for clinical research and ICH-GCP, as well as a clear understanding of roles and responsibilities of all stakeholders in clinical research. Certificates of completion are issued and are valid for two years.
National Health and Medical Research Council clinical trial training modules
The REGI Unit also recommends the new National Health and Medical Research Council (NHMRC) eLearning Modules which are particularly relevant to early career researchers and clinical trial coordinators.
These modules provide an introduction to the clinical trials environment, clinical research ethics and ethical review, as well as research governance processes. They are also a component of the Government's Expediting Clinical Trials Reforms Initiative to maintain Australia's position as a world leader in quality clinical research.
The learning objectives of the module are:
- To understand how clinical trials take place in Australia
- To understand and promote responsible research practices
- To ensure quality research outcomes
- To ensure participant safety is maintained at all times.
Each module takes approximately 45 minutes.
Education and training about research ethics and integrity
Invitation to attend a Barwon Health Human Research Ethics Committee meeting
The Barwon Health Human Research Ethics Committee (BH HREC) is pleased to invite researchers from within Barwon Health to observe a HREC meeting. Any interested researchers who are either planning on or have submitted ethics applications for review by the HREC are encouraged to attend. The REGI Unit believes that observing a HREC meeting could improve understanding of the research ethics processes and the role and objective of the HREC and may help researchers to improve their HREC applications. Committee dates are available on the Committees, meetings and dates webpage. Please contact the REGI Unit if you would like to attend.
Courses available through Deakin University
Researchers affiliated with Deakin University are encouraged to access the training available through Deakin University. The REGI Unit is able to organise access to some courses for non-Deakin Barwon Health staff. Deakin Research Integrity provides online or live induction and training in the following areas:
Human ethics training is compulsory for all Deakin University staff and students submitting an ethics application for the first time at Deakin (either DUHREC or to a Faculty HEAG). Regardless of whether the training is undertaken in person or online, it is necessary to complete the online quiz available on the D2L site.
Courses available through the University of Wollongong
The University of Wollongong offers free online human research ethics courses designed for researchers and members of Human Research Ethics Committees.
The REGI Unit recommends these modules to increase understanding of the principles and values that underpin ethical research conduct and familiarity with using the National Statement in human research ethics work.
Courses available through the Office of Research Integrity
The Office of Research Integrity (ORI) within the US Department of Health and Human Services, oversees and directs Public Health Service (PHS) research integrity activities and provides access to many training and education resources for research teams and supervisors.
The Research Clinic
The ORI and the Office for Human Research Protections (OHRP) present The Research Clinic. This interactive training video educates clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct. The Research Clinic allows the viewer to assume the role of one of four characters and determines the outcome of the storyline by selecting decision-making choices for each 'playable' character.
In this simulation, you get to become a principal investigator, a clinical research coordinator, a research assistant, and an institutional review board (IRB) chair and make decisions that affects the outcome of the story.
Researchers are also encouraged to view one or more of the below training videos:
- Human Participant Protections Education for Research Teams by the National Cancer Institute
- Protection for Human Subjects Training Video by the HRSA and OHRP
- Teaching the Responsible Conduct of Research in Humans by UCLA by UCLA
Last Modified: Tuesday, 26 February 2019